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Treatment of Suicidal Women With Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marsha Linehan, University of Washington
ClinicalTrials.gov Identifier:
NCT00183651
First received: September 13, 2005
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

This study is a component analysis of dialectical behavior therapy (DBT) to determine the importance of DBT skills training and DBT individual therapy in treating suicidal women with borderline personality disorder.


Condition Intervention Phase
Borderline Personality Disorder
Suicide
Behavioral: Standard dialectical behavior therapy (SDBT)
Behavioral: Individual DBT with no DBT group sessions (DBT-I)
Behavioral: Group Skills DBT with no DBT individual sessions (DBT-S)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment and Treatment of Parasuicidal Patients

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Suicidal thoughts or attempts [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coping skills [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: April 2004
Study Completion Date: June 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-DBT
Participants receive standard dialectical behavior therapy
Behavioral: Standard dialectical behavior therapy (SDBT)
Standard DBT includes: 1) individual DBT therapy (1 hour per week), 2) DBT group skills training (2.5 hours per week), 3) telephone consultation (as needed), and 4) therapist consultation team (1 hour per week).
Other Name: DBT, SDBT
Active Comparator: DBT-I
Participants receive individual dialectical behavior therapy plus activities group
Behavioral: Individual DBT with no DBT group sessions (DBT-I)
Individual DBT (DBT-I) is 1 hour per week of individual therapy and 2.5 hours per week with the psychosocial activities group.
Other Name: DBT, DBT-I
Active Comparator: DBT-S
Participants receive dialectical behavior therapy group skills plus case management
Behavioral: Group Skills DBT with no DBT individual sessions (DBT-S)
DBT group skills training is 2.5 hours per week and includes individual case management.
Other Name: DBT, DBT-S

Detailed Description:

People with borderline personality disorder have limited behavioral skills and react abnormally to emotional stimulation. Standard dialectical behavior therapy (SDBT) has been shown to be an effective treatment for borderline personality disorder. This treatment combines weekly group sessions, at which patients learn new ways of dealing with their emotions, with weekly individual sessions with a therapist to discuss their emotions. The study compares SDBT to both individual DBT with no skills training and DBT skills training with no individual therapy. The study will determine whether efficacy of standard DBT is reduced when either DBT skills training or individual DBT therapy is removed.

Participants are randomly assigned to receive 1 year of SDBT, DBT with group sessions but no individual sessions, and DBT with individual sessions with no group sessions. Participants are monitored for 1 year after completing their assigned therapy. Throughout the 1-year study and during the 1-year follow-up period, self-report scales and questionnaires are used to assess participants every 4 months. These scales and questionnaires measure participants' suicidal thoughts and attempts, treatment compliance, emotional coping skills, social functioning, and overall well-being.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of BPD
  • At least one suicide attempt in the year prior to study entry AND at least one intentional self-injury within the 8 weeks prior to study entry
  • Willing and able to comply with all study requirements

Exclusion Criteria:

  • IQ less than 70
  • Life-threatening anorexia
  • Street homelessness with no contact information
  • Admittance to a hospital with no expectation of discharge within 3 weeks prior to study entry OR sentenced to a jail or prison term that will last for more than 3 weeks
  • Ordered by the court to receive psychological treatment
  • Meet DSM-IV criteria for schizophrenia, bipolar disorder, or seizure disorder
  • Medical conditions other than BPD that may interfere with the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183651

Locations
United States, Washington
University of Washington, Department of Psychology, Behavior Research and Therapy Clinics
Seattle, Washington, United States, 98195-1525
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Marsha M. Linehan, PhD Department of Psychology, University of Washington
  More Information

Additional Information:
Publications:
Koons, Cedar R; Robins, Clive J; Tweed, J. Lindsey; Lynch, Thomas R; Gonzalez, Alicia M; Morse, Jennifer Q; Bishop, G. Kay; Butterfield, Marian I; Bastian, Lori A. Efficacy of dialectical behavior therapy in women veterans with borderline personality disorder. Behavior Therapy. Vol 32(2) Spr 2001, 371-390

Responsible Party: Marsha Linehan, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00183651     History of Changes
Other Study ID Numbers: R01 MH34486, R01MH034486
Study First Received: September 13, 2005
Last Updated: January 31, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Suicide
Women
Emotions
Psychotherapy, Group

Additional relevant MeSH terms:
Borderline Personality Disorder
Disease
Personality Disorders
Suicide
Behavioral Symptoms
Mental Disorders
Pathologic Processes
Self-Injurious Behavior

ClinicalTrials.gov processed this record on November 20, 2014